In a post-market CV outcome study (the CARES trial), 1 a higher rate of CV fatal outcomes has been reported in patients with gout and established cardiovascular disease treated with ULORIC, when compared to those treated with allopurinol (see Background section for more details). In order to mitigate the risk identified in the CARES trial, 1 the ULORIC CPM has been updated to include the revised indication for use and additional safety information.
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